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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04412551
Other study ID # LUS-Covid001
Secondary ID
Status Completed
Phase
First received
Last updated
Start date May 20, 2020
Est. completion date December 31, 2020

Study information

Verified date May 2021
Source Dalarna County Council, Sweden
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial Summary

This observational study will describe lung ultrasound (LUS) findings over time in hospitalized patients with moderate to severe Covid-19 lung disease. Our primary aim is to investigate if lung ultrasound can identify and/or predict patients requiring mechanical ventilation. Another aim is to describe LUS findings associated with clinical findings and patient condition.


Description:

Study patients with moderate to severe Covid-19 infection will be screened with lung ultrasound daily. Lung ultrasound will be assessed by LUS-score for acute respiratory distress syndrome (ARDS) (0-36 points, Bouhemad 2015). Findings of B-line artifacts and consolidations will be noted. In addition to LUS, clinical parameters from physical examination and laboratory tests will be collected. Participants wil be followed until either admission to intensive care unit (ICU) for mechanical ventilation or until clinical improvement. A group of patients with mild Covid-19 infection will be recruited and screened once as reference. Apart from assessment with LUS, patients are managed according to routine care.


Recruitment information / eligibility

Status Completed
Enrollment 72
Est. completion date December 31, 2020
Est. primary completion date December 31, 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years to 80 Years
Eligibility Inclusion Criteria: - Covid-19 confirmed by positive polymerase chain reaction (PCR) - oxygen by mask or nasal prongs = 4 l/min or high flow nasal cannula (HFNC) with fraction of inspired oxygen (FiO2) = 30% - age between 18-80 years - informed consent Exclusion Criteria: - patients subject to treatment-limitation "no ICU" - history of heart failure - history of lung disease e.g.: pneumonectomy, pulmonary fibrosis or other interstitial lung disease, pleurodesis - history of kidney failure requiring dialysis - any reason making lung ultrasound or daily follow up impossible - opposition to participation in the study

Study Design


Locations

Country Name City State
Sweden Falun Hospital Falun

Sponsors (1)

Lead Sponsor Collaborator
Dalarna County Council, Sweden

Country where clinical trial is conducted

Sweden, 

References & Publications (1)

Bouhemad B, Mongodi S, Via G, Rouquette I. Ultrasound for "lung monitoring" of ventilated patients. Anesthesiology. 2015 Feb;122(2):437-47. doi: 10.1097/ALN.0000000000000558. Review. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Identification of requirement of mechanical ventilation Assessment of LUS-score or findings of consolidations correlated to requirement of mechanical ventilation on ICU 3 weeks
Secondary Prediction of requirement of mechanical ventilation Assessment if LUS-score or findings of consolidations is able to anticipate clinical deterioration with requirement of mechanical ventilation on ICU 3 weeks
Secondary Association of LUS to clinical parameters Descriptive assessment of clinical parameters and LUS-score over time 3 weeks
Secondary Description of findings on LUS Description of quality and distribution pattern of LUS-findings in patients with different severities of Covid-19 3 weeks
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